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Landiolol HCl
Landiolol HCl is a Beta-1 selective adrenergic antagonist (beta-blocker) Small molecule drug developed by Medical University of Vienna. It is currently in Phase 3 development for Intraoperative and postoperative tachycardia, Atrial fibrillation with rapid ventricular response in perioperative settings. Also known as: Rapibloc.
Landiolol HCl is an ultra-short-acting beta-1 selective adrenergic antagonist that rapidly reduces heart rate and cardiac workload.
Landiolol HCl is a medication used to prevent atrial fibrillation after cardiac surgery. It is administered as a low-dose intravenous infusion.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Landiolol HCl |
|---|---|
| Also known as | Rapibloc |
| Sponsor | Medical University of Vienna |
| Drug class | Beta-1 selective adrenergic antagonist (beta-blocker) |
| Target | Beta-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Landiolol selectively blocks beta-1 adrenergic receptors on cardiac tissue, reducing sympathetic stimulation and decreasing heart rate, contractility, and blood pressure. Its ultra-short half-life (approximately 4 minutes) allows for rapid onset and offset of effect, making it suitable for acute perioperative and critical care settings where quick titration is needed.
Approved indications
- Intraoperative and postoperative tachycardia
- Atrial fibrillation with rapid ventricular response in perioperative settings
Common side effects
- Hypotension
- Bradycardia
- Injection site reactions
Key clinical trials
- Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery (PHASE3)
- Landiolol for Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery (PHASE3)
- Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers (PHASE1)
- Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan (PHASE2)
- Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan (PHASE2, PHASE3)
- Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Landiolol HCl CI brief — competitive landscape report
- Landiolol HCl updates RSS · CI watch RSS
- Medical University of Vienna portfolio CI
Frequently asked questions about Landiolol HCl
What is Landiolol HCl?
How does Landiolol HCl work?
What is Landiolol HCl used for?
Who makes Landiolol HCl?
Is Landiolol HCl also known as anything else?
What drug class is Landiolol HCl in?
What development phase is Landiolol HCl in?
What are the side effects of Landiolol HCl?
What does Landiolol HCl target?
Related
- Drug class: All Beta-1 selective adrenergic antagonist (beta-blocker) drugs
- Target: All drugs targeting Beta-1 adrenergic receptor
- Manufacturer: Medical University of Vienna — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Intraoperative and postoperative tachycardia
- Indication: Drugs for Atrial fibrillation with rapid ventricular response in perioperative settings
- Also known as: Rapibloc
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing